<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04571226474747</udiDi>
    <basicUdiDi>B-04571226474747</basicUdiDi>
    <tradeName>Determine</tradeName>
    <deviceName>Determine HIV Controls</deviceName>
    <manufacturerName>Abbott Diagnostics Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000009543</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094002</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS INFECTIOUS IMMUNOLOGY/NAT - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7D2253</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:56:07.879Z</lastUpdated>
  </row>
</eudamedExport>